NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Proposed Single Technology Appraisal (STA)
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1 NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Proposed Single Technology Appraisal (STA) Vedolizumab for treating moderately to serverely Provisional matrix of consultees and commentators Manufacturers/sponsors Takeda UK (vedolizumab) Patient/carer groups Afiya Trust Black Health Agency Bladder and Bowel Foundation Bowel Cancer UK Colostomy Association Crohn s and Colitis UK Equalities National Council Independent Age Muslim Council of Britain Muslim Health Network Ostomy Lifestyle South Asian Health Foundation Specialised Healthcare Alliance Ulcerative Colitis UK Professional groups Association of Coloproctology of Great Britain and Ireland British Association for Services to the Elderly British Geriatrics Society British Society of Gastroenterology Primary Care Society for Gastroenterology Royal College of General Practitioners Royal College of Nursing Royal College of Pathologists Royal College of Physicians Royal Pharmaceutical Society Royal Society of Medicine United Kingdom Clinical Pharmacy General Allied Health Professionals Federation Board of Community Health Councils in Wales British National Formulary Care Quality Commission Commissioning Support Appraisals Service Department of Health, Social Services and Public Safety for Northern Ireland Healthcare Improvement Scotland Medicines and Healthcare products Regulatory Agency National Association of Primary Care National Pharmacy Association NHS Alliance NHS Commercial Medicines Unit NHS Confederation Scottish Medicines Consortium Possible comparator manufacturers AbbVie (adalimumab) Accord Healthcare (methotrexate) Actavis UK (azathioprine, hydrocortisone, prednisolone, sulfasalazine) Amdipharm (prednisolone) Alliance Pharmaceuticals (prednisolone, Almirall (balsalazide) AstraZeneca (budesonide) Astellas Pharma (tacrolimus) Aspen (mercaptopurine) Auden McKenzie ( Bayer (prednisolone, Page 1 of 5
2 Association Others Department of Health NHS England NHS Thanet CCG NHS South Kent Coast CCG Welsh Government Bristol-Myers Squibb ( Chemidex Pharma (prednisolone, Chiesi (beclometasone Dermal laboratories ( Dexcel-Pharma (ciclosporin) Dr. Falk Pharma UK (budesonide, mesalazine) Ferring Pharmaceuticals (mesalazine) Focus Pharmaceuticals (beclometasone Galderma ( GlaxoSmithKline (hydrocortisone, beclometasone Hospira UK (methotrexate) Intrapharm Laboratories (prednisolone) Janssen ( LEO Pharma ( Meda Pharmaceuticals (hydrocortisone, beclometasone Merck Sharp & Dohme Limited (infliximab, golimumab) Mylan UK (azathioprine, sulfasalazine, ciclosporin, beclometasone Novartis Pharmaceuticals(ciclosporin, Orion Pharma (methotrexate) Pfizer (methotrexate, prednisolone, hydrocortisone, sulfasalazine) Ranbaxy UK (sulfasalazine) Rosemont Pharmaceuticals (sulfasalazine) Sandoz (azathioprine, mesalazine, methotrexate, tacrolimus) Shire Pharmaceuticals (mesalazine) Teva UK (azathioprine, sulfasalazine, mesalazine, prednisolone, hydrocortisone, beclometasone Tillotts Pharma (mesalazine) UCB Pharma (olsalazine) Warner Chilcott (mesalazine) Page 2 of 5
3 Wockhardt UK (prednisolone) Zentiva UK (prednisolone) Relevant research groups Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Group CORE (Digestive Disorders Foundation) Health Research Authority MRC Clinical Trials Unit National Institute for Health Research Research Institute for the Care of Older People Evidence Review Group Evidence Review Group tbc National Institute for Health Research Health Technology Assessment Programme Associated Guideline groups National Clinical Guidelines Centre Associated Public Health groups Public Health England Public Health Wales NHS Trust NICE is committed to promoting equality, eliminating unlawful discrimination and fostering good relations between people who share a protected characteristic and those who do not. Please let us know if we have missed any important organisations from the lists in the matrix, and which organisations we should include that have a particular focus on relevant equality issues. PTO FOR DEFINITIONS OF CONSULTEES AND COMMENTATORS Page 3 of 5
4 Definitions: Organisations that accept an invitation to participate in the appraisal; the manufacturer(s) or sponsor(s) of the technology; national professional organisations; national patient organisations; the Department of Health and the Welsh Government and relevant NHS organisations in England. The manufacturer/sponsor of the technology is invited to make an evidence submission, respond to consultations, nominate clinical specialists and has the right to appeal against the Final Appraisal Determination (FAD). All non-manufacturer/sponsor consultees are invited to submit a statement 1, respond to consultations, nominate clinical specialists or patient experts and have the right to appeal against the Final Appraisal Determination (FAD). Commentators Organisations that engage in the appraisal process but that are not asked to prepare an evidence submission or statement, are able to respond to consultations and they receive the FAD for information only, without right of appeal. These organisations are: manufacturers of comparator technologies; Healthcare Improvement Scotland; the relevant National Collaborating Centre (a group commissioned by the Institute to develop clinical guidelines); other related research groups where appropriate (for example, the Medical Research Council [MRC], National Cancer Research Institute); other groups (for example, the NHS Confederation, NHS Alliance and NHS Commercial Medicines Unit, and the British National Formulary. All non-manufacturers/sponsors commentators are invited to nominate clinical specialists or patient experts. Evidence Review Group (ERG) An independent academic group commissioned by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (HTA Programme) to assist the Appraisal Committee in reviewing the manufacturer/sponsor evidence submission to the Institute. 1 Non manufacturer consultees are invited to submit statements relevant to the group they are representing. Page 4 of 5
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NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Proposed Single Technology Appraisal
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